Catalog Number

441507

Brand Name

Dermacea

Version/Model Number

441507

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FQM

Product Code Name

BANDAGE, ELASTIC

Public Device Record Key

58dd6371-0870-4264-bc89-dc6c609c4301

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Package DI Number

30884527021059

Quantity per Package

48

Contains DI Package

10884527021055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE